Kornimate/medical-research-clean huggingface dataset:
pilot study to examine health effects of daylight exposure on dementia patients

Conditions: Dementia; Depression; Behavior Disorders

Summary: this study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities.

exposure to sufficient daylight indoors is a novel and potentially effective nonpharmacological treatment option for reducing depression and other neuropsychiatric symptoms for people living with dementia in long term care facilities. however, there are currently no minimum requirements for daylight access in care facilities. in urban settings, it is common for residents to spend the majority of the day indoors, illuminated by electrical light sources that deliver light with significantly lower intensities and reduced spectrum compared with daylight. a 12-week pilot study was conducted in 8 dementia care facilities involving (n = 83) participants addressing the hypothesis that an intervention increasing indoor exposure to daylight will reduce depression and other neuropsychiatric symptoms. at 4 facilities, staff was enlisted to increase daylight exposure by taking participants to a perimeter room with daylight exposure for socialization in the morning (8:00 - 10:00 am) each day. at the other 4 facilities, a control group were taken to a similar sized area without daylight for socialization under typical electrical lighting conditions. outcome measures for depression and other neuropsychiatric symptoms were taken at the beginning and end of the 12-week study.

Eligibility criteria:
inclusion criteria: * residents were recruited according to the trial inclusion criteria: 1) alzheimer's disease and related dementias (adrd) diagnosis, 2) no physical co-morbidities that precluded participation in the daily group intervention, and 3) a mini-mental state exam (mmse) score of 10 or higher exclusion criteria: * physical co-morbidities that precluded participation in the daily group intervention
the effect of pelvic floor muscle training with biofeedback and extracorporeal magnetic innervation on the urinary symptoms, sexual function and quality of life

Conditions: Urinary Incontinence

Summary: the effect of pelvic floor muscle training with biofeedback and extracorporeal magnetic innervation on the urinary symptoms, sexual function and quality of life of women with stress urinary incontinence

introduction and hypothesis: this research was made in order to analyze the impact of the with with electromyelographic-biyofeedback added extracorporeal magnetic innervation technique performed on the urinary symptoms, quality of life and sexual function of women with stress urinary incontinence. methods: the research type is a pre-test and post-test randomized controlled with experimental nature. the research sample consists of 26 patients in the biyofeedback group and 25 patients in the with electromyelographic-biyofeedback added extracorporeal magnetic innervation group who were examined in the urogynecology policlinics and diagnosed with stress urinary incontinence. between september 2015 and september 2016. at the first meeting, the case report form is filled and the following list is applied for each patience: incontinence life quality scale, female sexual function scale, q-type test, residue urine volume, one-hour pad test, perineometer, muscle force measurement with modified oxford scale and a three-day bladder diary. moreover, the electromyelographic-biyofeedback was applied to the first group in the clinic for 20 minutes two days a week for eight weeks. the electromyelographic-biyofeedback following with 20 minutes extracorporeal magnetic innervation was applied to the second group in the clinic for 20 minutes two days a week for eight weeks. the list applied at the first meeting were repeated after eight weeks.

Eligibility criteria:
inclusion criteria * patients diagnosed with stress urinary incontinence * with pelvic floor power 2 and over, * sexually active and no restrictions for the magnetic chair treatment. exclusion criteria: patients with * prosthesis, * other implanted metallic devices, * cardiac pacemaker, * arrhythmia, * pelvic malignancies, * under radiotherapy, * pelvic floor defect, * previous surgery for urinary incontinence, * neurological diseases * pregnancy.

Keywords: stress urinary incontinence quality of life sexual function
patient comfort during dermatologic procedures

Conditions: Pain; Anxiety

Summary: the goal of this study is to find the effect of holding a patient's hand on anxiety and pain during dermatologic procedures.


Eligibility criteria:
inclusion criteria: * age 18 and older * undergoing a dermatologic procedure * willing and able to understand and provide informed consent and communicate with the investigator exclusion criteria: * subjects who have wound healing problems * subjects who are unable to understand the protocol or to give informed consent * subjects with self-reported mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders, cognitive disorders, depression with psychotic features, dissociative disorders
breast cancer trial of rpr109881 versus capecitabine in male or female patients with advanced breast cancer

Conditions: Breast Cancer; Metastases

Summary: the purpose of this clinical trial is to determine if rpr109881 is a better treatment than capecitabine (xeloda) for advanced breast cancer in patients that no longer benefit from docetaxel and/or paclitaxel.

all patients in this trial will receive either the investigational drug or capecitabine, a chemotherapy drug that is already approved to treat your disease. these drugs prevent tumor cells from dividing, so they may stop growing or die. the investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks. patients who receive capecitabine will receive this drug by mouth for 14 days, every 21 days.

Eligibility criteria:
eligibility criteria in order to be eligible for this trial you must: * have a diagnosis of breast cancer that is now metastatic (meaning the cancer has spread beyond its original location) or a recurrence of the cancer in its original location that cannot be removed by surgery. * have received previous treatment with anthracyclines (e.g., adriamycin, doxorubicin) and taxanes (e.g., paclitaxel, docetaxel, taxol®, taxotere®) for your breast cancer and your doctor has determined that these treatment are no longer of benefit to you. * be at least 18 years of age. * not be taking other treatments for your cancer at the time you enter this trial. * not be pregnant. additionally, there are other criteria for study entry that a doctor participating in this study will need to review in detail with you and clinical assessments may need to be performed (e.g., lab tests, ct scans).

Keywords: metastatic breast cancer
clinical evaluation of different potassium oxalate concentrations in dentin hypersensitivity treatment

Conditions: Dentin Sensitivity; Hypersensitivity Dentin; Dentine Hypersensitivity; Dentin Hypersensitivity

Summary: this study aims to evaluate the longevity and efficacy of two products potassium oxalate-basedin two concentrations, 10% and 5%, by triple randomized blind clinical trial (split-mouth) . the desensitization approach (single agent) and the long-term effectiveness (baseline, 1 week, 2 weeks, 3 weeks). data will be collected, tabulated and submitted to statistical analysis.

dentin hypersensitivity (dh) is characterized as a short, intense and sudden pain caused by thermal, chemical and evaporative stimuli. there are several types of desensitizing agents, used to aid in the control of this pathology, but they are not very effective and have short longevity. the agents based on potassium oxalate have been used by dental surgeons because they have mixed action, both neural and obliterating. therefore, the aim of this study is through a triple blind randomized clinical trial (split-mouth), evaluate the longevity and efficacy of two products potassium oxalate-based in two concentrations, 10% and 5%. thirty-two with dh at least 2 teeth and adequate oral hygiene will be randomly divided into two different groups according to the desensitization approach (10% and 5%) the dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2 and 3. data will be collected, tabulated and submitted to statistical analysis.

Eligibility criteria:
inclusion criteria: * healthy individuals * both genres, interested in the treatment of dentin hypersensitivity * patients with all teeth in their mouth * patients who have at least three teeth with dentin hypersensitivity in different quadrants * good oral hygiene exclusion criteria: * caries or unsatisfactory restorations * presence of periodontal disease and or parafunctional habits * cracks or enamel fractures * extensive or unsatisfactory restorations * recent restorations involving the labial surface * pulpitis * dentures * orthodontics * smokers * pregnant women * gastroesophageal disease presence * uncontrolled systemic disease * severe bruxism * constant use of analgesic * allergic response to dental products
impact of brief motivational interviewing on periodontal clinical outcomes: a 3-year post-trial follow-up

Conditions: Periodontal Diseases; Plaque Score; Bleeding on Probing; Gingival Index

Summary: the objective is a 3-year follow-up clinical trial to evaluate longitudinal indicators of periodontal disease (plaque score, bleeding on probing (bop), and gingival index (gi)) in 58 participants who completed nct03571958. these participants were randomized to a brief motivational (bmi) test group or a traditional oral hygiene instruction (ohi) group for a 1-year clinical trial from 2018-2020. in addition, analysis of retrospective data to determine health topics that emerge from the behavior change strategy of bmi compared to traditional ohi by transcription of audio recordings from 2018-2020.


Eligibility criteria:
inclusion criteria: ° completed all study visits of study00003697 (nct03571958) exclusion criteria: * current smoker or quit smoking within the last year * pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported) * uncontrolled diabetes (hba1c \> 7) * medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or hiv/aids) * current use of oral bisphosphonates * history of iv bisphosphonates * require pre-medication or on long-term antibiotics * current orthodontic treatment or planning to begin orthodontic treatment during the study * unable to comply with the study protocol
re-evaluation of systemic early neuromuscular blockade and transthoracic ultrasound assessment of the diaphragm

Conditions: Acute Respiratory Distress Syndrome; Diaphragm Injury; Neuromuscular Blockade

Summary: rosetta is a multi-centre study evaluating the time course of diaphragm thickness and function following exposure to neuromuscular blockade or control in patients with acute respiratory distress. rosetta is an ancillary study to the re-evaluation of systemic early neuromuscular blockade (rose) trial (nct02509078). it is designed to (1) test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation and (2) determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome (ards).

a growing body of evidence strongly suggests that mechanical ventilation injures the respiratory muscles, particularly the diaphragm. due to the deleterious effects of diaphragm inactivity on diaphragm function, there are important concerns about the risk of diaphragm weakness and difficult liberation from mechanical ventilation following neuromuscular blockade. sonographic measurements of diaphragm thickness provide a potentially useful window for studying diaphragm injury and function during mechanical ventilation. patients enrolled in the rose trial (randomizing patients with moderate-severe acute respiratory distress syndrome to receive neuromuscular blockade or control for 2 days) will be eligible for participation in this study. study patients will undergo regular diaphragm ultrasound to assess diaphragm thickness and activity during the first week of the study. diaphragm function will be assessed by ultrasound on study days 7, 14, 21, and 28. rosetta is designed to: 1. test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation; 2. determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome; and 3. evaluate whether patients with greater diaphragm dysfunction exhibit worse functional outcomes compared to patients without diaphragm dysfunction.

Eligibility criteria:
inclusion criteria: 1. patients enrolled in the rose petal trial (adult patients with moderate-severe acute respiratory distress syndrome who have received invasive mechanical ventilation for less than 5 days) exclusion criteria: 1. patients expected to be extubated within 24 hours of screening for eligibility 2. patients with a contraindication to chest ultrasonography (chest tubes inserted over right lower chest wall; chest wall trauma)
liquid guide catheter extension safety study

Conditions: Coronary Artery Disease

Summary: single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the liquid guide catheter extension

the study will consist of evaluating the safety and performance of the liquid guide catheter extension (gce) compared to historical data. the safety measures will consist of procedural major adverse cardiac events (mace) while performance measures will include device oriented clinical outcomes.

Eligibility criteria:
inclusion criteria - participants must be: 1. scheduled for non-emergent, percutaneous coronary procedure in which the use of a guide catheter extension is anticipated 2. able to provide informed consent to participate in the study exclusion criteria - participants must not have: 1. evidence of ongoing st-elevation myocardial infarction (stemi) or stemi treatment for late presentation stemi with index admission (stabilized acute coronary syndrome allowed) 2. left ventricular ejection fraction \<20% 3. required intervention in a saphenous vein graft 4. an intolerance or known allergy to medications/contrast expected to be used during the procedure or during hospital stay 5. had a cardiac intervention within two weeks of the procedure 6. renal insufficiency (serum creatinine of \> 2.3 mg/dl) 7. active gastrointestinal bleeding 8. an active infection or fever (\>37.8º c) that may be due to infection 9. significant anemia (hemoglobin \< 8.0 mg / dl) 10. severe uncontrolled systemic hypertension (systolic press. \> 240 mm hg within the past month) 11. a severe electrolyte imbalance 12. congestive heart failure (nyha class iv) 13. presented with an acute coronary syndrome where serum troponin concentrations have not been demonstrated to be declining prior to the scheduled procedure (within the past two weeks) 14. uncontrolled diabetes (\> 2 serum glucose concentrations of \> 350 mg/dl within the past 7 days) 15. participation in an investigational protocol 16. unwillingness or inability to comply with any protocol requirements 17. angina, or ischemia caused by occluded artery 18. other clinical conditions, that in the opinion of the investigator significantly compromise the ability to perform a safe and/or effective procedure vulnerable population exclusion - participants must not be: 1. under 18 years old 2. pregnant or nursing 3. immuno-compromised 4. over 89 years old 5. incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent (including emergency situations)
a phase ii trial of high dose-rate brachytherapy as monotherapy in low and intermediate risk prostate cancer

Conditions: Carcinoma of the Prostate

Summary: a single high dose rate brachytherapy (hdr) treatment combined with a short course of external beam radiotherapy (ebrt) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. high cancer control rates have also been reported with hdr used on its own, without the ebrt. the challenge has been to determine what hdr dose to use with a move towards one or two fractions by several investigators. these schedules are reported to be well tolerated in the short term, but with little long term data. the objective of this study is to investigate hdr monotherapy given as either one fraction of 19 gy or two fractions of 13.5 gy in a randomized phase ii clinical trial. the primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. sample size for the study is 174 patients, which we expect to accrue within 18 months.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of adenocarcinoma of the prostate * low and intermediate risk disease defined as either gleason 6 or gleason 7 and psa \< 20ng/ml. psa to be drawn within 60 days of registration * prostate volume \< 60 cc as determined by ultrasound, ct or mri * willing to give informed consent ot participate in this clinical trial * able and willing to complete expanded prostate index composite (epic) questionnaire exclusion criteria: * documented nodal or distant metastases * previous pelvic radiotherapy * previous trans-urethral resection of prostate, previous prostatectomy or highly focused ultrasound (hifu) * use of androgen deprivation therapy. use of 5-alpha reductase inhibitors is permitted * poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease * significant medical co-morbidity rendering patient unsuitable for general anaesthetic

Keywords: hdr monotherapy low intermediate prostate cancer
empyema treated with tpa & dnase

Conditions: Empyema

Summary: the objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tpa. the hypothesis, driven by a recent prospective trial, is that tpa may benefit from the addition of dnase. the primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.


Eligibility criteria:
inclusion criteria: patients less than 18 years of age requiring an intervention for empyema by one of the following: * septation or loculation seen on ultrasound or computed tomography or * greater than 10,000 white blood cells identified on pleural tap exclusion criteria: * immunodeficiency process * secondary diagnosis or condition that will keep them in the hospital beyond the empyema * existing contraindications to chest tube * documented allergy to one of the study medications

Keywords: empyema tpa dornase
sorafenib phase ii study for japanese anaplastic or medullary thyroid carcinoma patients

Conditions: Thyroid Carcinoma

Summary: the objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of japanese patients with anaplastic thyroid carcinoma (atc) or locally advanced or metastatic medullary thyroid carcinoma (mtc).


Eligibility criteria:
inclusion criteria: * japanese patients with atc (anaplastic thyroid carcinoma) or locally advanced or metastatic mtc (medullary thyroid carcinoma) * not a candidate for surgery or radiotherapy with curative intent * histologically or cytologically confirmed atc or mtc * measurable or non-measurable disease (but clinically evaluable) according to recist 1.1. * age \>= 18 years * adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * life expectancy of at least 12 weeks exclusion criteria: * histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma * prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target vegf or vegf (vascular endothelial growth factor) receptors or other targeted agents * prior chemotherapy for thyroid cancer (only one regimen is allowed) * major surgery, open biopsy, or significant traumatic injury within 30 days prior to enrollment in the study. * subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding but without having received local treatment prior to enrollment in the study

Keywords: anaplastic and medullary thyroid carcinoma thyroid neoplasms
treatment of egg allergy in children through oral desensitization (egg oit)

Conditions: Food Hypersensitivity

Summary: the purpose of this study is to determine if children with egg allergy can be desensitized to egg protein and if this desensitization can help them outgrow their egg allergy at an earlier time than normal. our hypothesis is that children with egg allergy can be orally desensitized to egg protein and that this desensitization will help them outgrow their egg allergy at an earlier time than normal.

egg allergy in children under 5 years of age is extremely common. egg, along with milk and peanuts, cause 80% of the food allergy reactions in children in the united states. children have allergic reactions to egg ranging from mild urticaria to systemic anaphylaxis. the current therapy for children with egg allergy is to place the child on an egg-free diet until the allergy is outgrown. because egg protein is a part of a significant number of processed foods it is difficult to totally avoid all egg proteins. accidental ingestions leading to reactions to egg can occur with a bite of a cookie (\~70 mg of egg protein) or a bite of a cake (\~55 mg of egg protein). children typically do not outgrow their egg allergy for several years. therefore it would be helpful if a specific form of therapy would make children outgrow their allergic reactions to egg sooner. egg protein is given to children in this study in small increasing amounts to desensitize them to the egg protein with the goal of helping them to outgrow their allergy.

Eligibility criteria:
inclusion criteria: * between 1 to 16 years of age * diagnosed egg allergy by cap feia to egg of 5 ku/l or greater (2 ku/l or greater if 2 years old or less) or have had a positive allergic reaction to egg within 6 months. * having eaten egg in his/her diet prior to diagnosis * a family that will be able to be compliant with all study visits * all females of child bearing age must be using appropriate birth control exclusion criteria: * history of anaphylaxis to egg * medical history that would prevent a dbpcfc (double-blind placebo-controlled food challenge) to egg. the medical history that would prevent the dbpcfc to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an fev1 \< 80% of predicted, or fev1/fvc \<75%, with or without controller medications * unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up * diagnosed corn allergy

Keywords: egg allergy